FDA.reportPublic FDA data

Endoch

Primary DI
EAI0817
Brand
Endoch
Company
Endoch Inc
Model
EAI-0817
Catalog number
EAI-0817
Device description
DISPOSABLE LAPAROSCOPIC MICRO SCISSORS, CURVED
Published
2019-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
JOKScissors, Medical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
JOKScissors, Medical, DisposableGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171825000Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd.2018-02-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAI0817PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure monitoring damping deviceA small, sterile, non-powered device intended to be placed between external components of an invasive blood pressure monitoring tubing set (e.g., between intra-arterial line and transducer) to improve the accuracy of the pressure measurement. It is in the form of a connector with an additional section containing an air chamber and diaphragm. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241382683
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GS3300EndochGS-330GS-3302019-06-01
GS3309EndochGS-330BGS-330B2019-06-01
GS4300EndochGS-430GS-4302019-06-01
GS4307EndochGS-430LGS-430L2019-06-01
GS5000EndochGS-500GS-5002019-06-01
GS5007EndochGS-500LGS-500L2019-06-01
B747EAI0496EndochEAI-0496EAI-04962019-10-01
B747EAI0502EndochEAI-0502EAI-05022019-10-01
B747EAI0503EndochEAI-0503EAI-05032019-10-01
B747EAI0535EndochEAI-0535EAI-05352019-10-01
B747EAI0628EndochEAI-0628EAI-06282019-10-01
B747EAI0784EndochEAI-0784EAI-07842019-10-01
B747EAI0785EndochEAI-0785EAI-07852019-10-01
B747EAI0787EndochEAI-0787EAI-07872019-10-01
B747EAI0788EndochEAI-0788EAI-07882019-10-01
B747EAI0793Endoch EAI-0793EAI-07932019-10-01
DGF23181EndochDGF-2318ADGF-2318A2019-06-03
DGF231858EndochDGF-2318RTDGF-2318RT2019-06-03
DGF23189EndochDGF-2318GDGF-2318G2019-06-03
DGF23231EndochDGF-2323ADGF-2323A2019-06-03

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Primary DI, Brand, Company table
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